Intermezzo: A Nightmare Drug for Insomniacs?

A new sleeping pill is on the market for patients with insomnia. Its name is Intermezzo and what makes this sleeping pill unique and potentially dangerous is that it is for “middle of the night” insomnia. The drug is made by Transcept Pharmaceuticals and is being marketed by Purdue Pharma (the maker of OxyContin) as their latest blockbuster drug. Purdue Pharma is spending $100 million on sales and marketing to promote Intermezzo.

The spearmint flavored drug is taken sublingually (under the tongue) and is meant to be taken “while in bed.” The active ingredient is zolpidem, which is also the active ingredient in the popular sleeping pill Ambien. By taking Intermezzo sublingually about 25% of the dosage is quickly absorbed through the tissues of the mouth, producing a rapid onset of sleep — thus the rationale for taking the sleeping pill while in bed. The remainder of the dose is swallowed and maintains sleep for the rest of the night.

The FDA says the drug is a “safer choice” than Ambien because it contains a smaller dose of zolpidem. “With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving,” said Robert Temple, MD, deputy center director for clinical science for the FDA.

The risk of next-day driving impairment is increased if Intermezzo is taken with alcohol or other drugs. And the label warns people not to drive for at least one hour after waking and at least five hours after taking Intermezzo.

Side Effects of Intermezzo

The FDA approved Intermezzo after two small clinical trials involving only 370 patients. The studies were relatively short (a few weeks in duration), and it is not clear if the drug is effective or can cause addiction when used for more than 35 days. The most common adverse reactions to Intermezzo in the trials were headache, nausea and fatigue.

When patients wake in the morning, they should wait until they are fully awake before driving or engaging in other activities requiring mental alertness. Patients should not do dangerous activities until they know how Intermezzo affects them. Abnormal thinking and behavior changes have been reported in patients while under the influence of sleep medicines such as zolpidem; including driving or eating while not fully awake, having sex, talking on the phone, sleep walking, hallucinations and other bizarre behavior that patients often have no recollection of doing.

I have problems with Intermezzo — big problems. First, it is being marketed by a pharmaceutical company that lied about a very dangerous drug called OxyContin. We are now immersed in OxyContin deaths and addictions throughout the U.S. and Canada because of Purdue Pharma’s criminal marketing.

Intermezzo came on the market in early April. But under FDA rules, Purdue cannot advertise the drug to the public until it has been on the market for at least six months. So for now, Purdue is relying on its sales force – which is marketing Intermezzo directly to doctors.

While talking to my primary care physician recently I asked him about Intermezzo. He was familiar with the drug and impressed with it. I told him that I had concerns with any sleeping pill being taken at 3:00 am and the patient being able to get behind the wheel of a car to drive to work. He told me to do more research before I wrote about Intermezzo because a pharmaceutical representative had told him Intermezzo was to be taken at bedtime — just as Ambien is.

Purdue Pharma representatives lied to the medical profession when they aggressively marketed OxyContin as less likely to be addictive or abused. They couldn’t possibly be repeating this criminal marketing ploy with Intermezzo could they? You interested FDA? Or will you wait until Intermezzo is a train wreck as OxyContin is in every state in the country?

Marianne Skolek is an activist and investigative reporter for Salem-News.com who lost a daughter to prescribed OxyContin in 2002. Marianne writes from the perspective of families devastated by the prescription drug epidemic.

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It is apparent that you have never struggled with insomnia. After trying several anti depressants and other sleep meds that either did not work or was way too strong of a medication, I have found this med to be very beneficial. I have tried all supplements, accupunture and had several tests done to explain why I can’t sleep more than 3 hours at a time. I go to sleep fine and then wake up just 3 hours later and cannot manage to sleep deeply the rest of the night.

I am a responsible person who would not take this med if I did not have a full four hours of sleep to continue. It has been extremely helpful to me and my health. I wake up alert and ready to start my day full of energy and much more clearer thinking than I would if I did not have assistance. Sleep deprivation is very dangerous to ones health and mood as welll. As with any sedative medicine you have to be careful. This is such a low dose that I believe it is much safer than the stronger meds on the market.

You should be ashamed of yourself. At best, your reporting is irresponsible. Are you a medical professional? Are you qualified to review evidence from the FDA-mandated drug trials? Do you understand the mechanism of action, bio-availability and how quickly it is eliminated from the body? I understand your emotional attachment to the use and abuse of opioids but “stories” such as this only divert attention away from the real problem – the misuse of dangerous drugs by people who do not have a legitimate need for them.

You should listen to your PCP. It appears that he understands how zolpidem can help insomniacs get back to sleep after awakening in the middle of the night. All drugs have side effects and they vary from patient to patient. Nobody should assume that they can start a sedative / hypnotic medication and continue their normal routine without considering the impact that such a medication may have on them. Any responsible doctor will discuss this with their patient as will a pharmacist when filling an initial prescription for Intermezzo.

I am not a doctor and I have never been employed in the health care industry in any capacity. My personal experience with zolpidem was unsatisfactory. Taking it occasionally (two or three times a month) everything seemed fine at first. That continued to be my opinion until I learned that my wife had found me “sleep eating”, standing in front of an open refrigerator and stuffing food in my mouth. I’ve not taken another since then. I do know other people who have fantastic results with it. Does my experience mean they shouldn’t have access to it? No, nor should your daughter’s experience prevent anyone from responsibly taking their medications.

I have a problem with this type of “reporting,” because it really isn’t reporting. You basically wrote the definition of Intermezzo, and a small blurb about a completely different product also marketed by Purdue Pharma. Executives at companies like Phillip Morris have lied about the health risks of smoking, but did you ever stop eating products made by Kraft Foods (which, until recently was owned by Phillip Morris (now known as Altria))?

Not once do you mention Transcept Pharma, the maker of the product known as Intermezzo. You have a completely biased opinion of the marketer of the drug, because of personal experience with one type of drug they marketed. Oxycontin is an opiate (which is a narcotic, and can only be perscribed by a doctor), which are well known to be genetically addictive. The active ingredients in Intermezzo on the other hand are not addictive in nature. Anything can become a danger to someone with an addictive personality.

Your “story” is a personal rant. Anyone who read your “report” and skipped the footnote, missed why you want this drug to fail. Sleeping disorders are the largest disorder facing Americans, and you have the audacity to ostracize an aid that can help millions of people with a condition with until-now unmet medical help.

I’m not saying Intermezzo is the cure, but the analogy is: you don’t like pears and because pears are fruit, you must not like apples too.